Design verification and validation

The main aim of doing this is to avoid the pain of expensive recalls, costly product rework, and unexpected delay in the fabrication. The major factor influencing this is the lack of an effective product design verification and validation process. Verification and validation is the process of ensuring that a design meets requirement. Verification confirms that the products properly reflect the requirements specified for them, ensuring that you built it right. Validation confirms that the product as provided, will fulfill its intended use, ensuring that you build the right thing”. Typical inputs are requirements and design representations such as 2D/3D mechanical CAD drawings and models, electrical schematics, and software code. Typical outputs are determination of whether a design component or system met requirements, description of failure modes, summarized test results and recommendation for design improvements.

Verification is strictly a paper exercise. It starts with taking all the design inputs: specifications, government and industry regulations, knowledge taken from previous designs, and any other information necessary for proper function. With these requirements in hand you compare to your design outputs: drawings, assembly instructions, test instructions, and electronic design files.

Design Requirement

C/NC

(Compliance/Non Compliance)

Verification

Max size= 1” * 2”* 3”

C

Drawing #A12345

If the design requirement is not met, then it should be ensure whether the requirement shall be relaxed.

Example for design validation:

Design Requirement

C/NC

(Compliance/Non Compliance)

Verification

Value

Validation

Max size= 1” * 2”* 3”

C

Drawing A12345

.98”* 1.8” *2.95”

Report order#12645

In this case the actual products specification is validated from the result of verification.After validation, the full set of requirements on one unit of most products can have a reduced level of inspection and testing, depending on factors such as requirements criticality or manufacturing process capability. A good product validation can help decide which requirements need to be checked on every product, and which do not.